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Completed

NCT Number: NCT05846386

Early Resistance Training Post Valve Replacement Surgery

Background: Recent recommendations from the European Society of Cardiology (ESC) are multidisciplinary cardiac rehabilitation including therapeutic exercises for patients after heart valve surgery unless there is insufficient evidence to decide whether therapeutic exercise cardiac training should be provided for such patients. As well, resistance training is an extremely safe systemic physical activity, and it has no contraindications if well-oriented, in addition to being the fastest-growing physical activity in the world in several practitioner settings.

Purpose: This study was conducted to investigate the effect of early resistance training on the fitness level (vo2 max) and (PR interval) of patients post-valve replacement surgery.

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Key information

Conditions

Valve Disease, Heart Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National heart institute

Giza, Cairo Governorate, 11262, Egypt

About this study

Method: Forty males post-valve replacement surgery participants' age ranged from 20 to 30 years old and were selected randomly from National Heart Institute (Imbaba), this study was conducted in the period between April and November 2022, and those participants were allocated randomly into two equal groups twenty in each group. Group A received aerobic and resistance training three sessions per week for one-month, and group B received aerobic training three sessions per week for one month. All demographic data was recorded and an ECG device was used to record HR and R-P Intervals, Six-Minute Walk Test (6MWT) was used to assess of cardiorespiratory fitness for all participants in both groups (A&B)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants' age ranged from 20 to 30 years old,
  • Participants medically stable to do early resistance exercise in the first week after the operation.
  • Each participant had undergone valve replacement surgeries only,
  • Participants be able to do early resistance exercises in the first week after the operation.

Exclusion criteria

  • The study excluded the participant if has one or more of the following criteria:
  • sternal infection and delay sternal healing.
  • Patient with a musculoskeletal condition limiting the ability to exercise or a geographical residence and/or lack of access to transportation, thus preventing exercise session attendance.
  • The patient has an LV thrombus diagnosed by echocardiography, left ventriculogram, or other imaging.
  • The patient is known to have unprotected left main coronary artery disease (CAD) greater than 50%.
  • Patients have poor cognitive capabilities or poor mentality.
  • Patient who had valve and CABG surgery.

Treatment and study plan

Resistance training

Behavioral

moderate-intensity resistance training: three sessions per week for one month. Participants had been instructed to perform exercises at a 4:2:4 tempo; that is, four sets of concentric contraction, two sets of isometric hold, and four sets of eccentric contraction. Participants had been instructed to complete a single set until volitional fatigue or been instructed to stop by the physiotherapist when the technique falters

Aerobic training

Behavioral

The exercise program consisted of ten minutes warm-up, 45 minutes of moderate aerobic exercises "upper extremity aerobic bulk muscles training and arm ergometer" and cool-down in five minutes, respectively. That was done as 3 sessions/week for 4 weeks.

Primary outcomes

  1. six minute walking distance (in meters)

    Time frame: 4 weeks

    represent aerobic capacity (distance walked in 6 min)

  2. P-R interval (in milliseconds)

    Time frame: 4 weeks

    represent a mortality index (the time from the beginning of atrial depolarization to the onset of ventricular depolarization) on the electrocardiograph

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Federation University Australia
  • RMIT University, Melbourne, Australia

Registry information

Official study title

Effects of Early Resistance Training on Functional Capacity and Electrocardiographic Changes Post Valve Replacement Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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